Freelance Sterile Construction Project Manager: Pharmaceutical Fit

A firm on gig Bench needs an owner-side Construction Project Manager for a sterile facility fit out at a pharmaceutical manufacturing site in the Delaware area. This is a full-time, on-site engagement of roughly one year, and the team runs lean, so you'll need to be ready to start immediately with no ramp-up period.

As the owner's representative, you'll hold the general contractor accountable to its schedule, cost and bid. You won't direct the GC's means and methods. Your job is to verify that the GC delivers what it committed to and follows the agreed processes.

• Hold the GC to its contract, bid and scope, and flag any gap between what was bid and what is being built or billed
• Lead weekly owner and GC progress meetings and track action items to closure
• Verify the GC's weekly schedule updates in the field, challenge unsupported forecast dates, and require recovery plans when activities slip
• Confirm the schedule reflects equipment deliveries, utility tie-ins, commissioning, CQV turnover and operational readiness milestones
• Enforce formal change control, evaluate change orders for entitlement, pricing and schedule impact, and maintain the change log
• Validate pay applications against work actually installed
• Manage the RFI process between the GC and engineering team, along with shop drawings, submittals and procurement tracking
• Review in-progress work against specifications and drawings, and confirm field documentation supports System Turnover Packages
• Coordinate across the GC, trades, design team, equipment vendors, CQV, Quality, Operations, EHS and facility stakeholders

• 3 to 5 years of owner-side or construction management experience on projects with filling and process equipment (OSD packaging experience is a plus)
• A track record of holding GCs accountable through schedule reviews, change order evaluation, pay application validation and RFI management
• Working knowledge of CPM scheduling tools such as Primavera P6 or Microsoft Project
• Availability for full-time on-site presence through construction, equipment installation, testing, turnover and startup

• Process piping and mechanical systems, including ASME B31.3 and ASME BPE, weld documentation, pressure and leak testing, and passivation
• Clean utilities and containment, such as WFI, clean steam, CIP/SIP, OEB banding, and isolator and RABS interfaces
• Controls and equipment, including BMS, room pressure monitoring, and FAT/SAT follow-up for filling, inspection and packaging equipment
• cGMP (21 CFR 210 and 211), Good Documentation Practices, ALCOA+ and construction turnover into CQV
• Cleanroom and occupied facility work, including gowning, ISO classification hand-off, permit to work, LOTO, and contamination control near GMP areas
• Familiarity with ISPE Baseline Guides and Good Practice Guides for sterile facilities

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